ICH S9 Non-clinical evaluation for anticancer pharmaceuticals

This document aims to assist in the design of non-clinical studies for the development of anticancer pharmaceuticals. It provides recommendations for non-clinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options.

Keywords: Anticancer pharmaceuticals, advanced cancer, pharmacology, pharmacokinetics, toxicology, non-clinical

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PDF iconQuestions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals, Step 5

Published: 16/05/2018
Effective from: 16/11/2018

Questions and answers

This Q&A document is intended to provide additional clarification relating to the selection and justification of starting materials

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